A Study of ONO-1110 in Patients With Social Anxiety Disorder

A Phase IIa, Randomized, Double-blind, Placebo Controlled, Parallel Group, Multi-center Trial to Evaluate the Efficacy and Safety of ONO-1110 in Patients With Social Anxiety Disorder

To Evaluate the Efficacy and Safety of ONO-1110 in Patients with Social Anxiety Disorder

Study Overview

• Status: Active, not recruiting
• Conditions: Social Anxiety Disorder (SAD)
• Intervention / Treatment: Drug: Placebo; Drug: ONO-1110

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Japan
    • Hirota Clinic
  • Fukuoka, Japan
    • Kokura Mental Clinic
  • Fukuoka, Japan
    • Aisakura Clinic
  • Fukuoka, Japan
    • AK Clinic
  • Fukuoka, Japan
    • Hiro Mental Clinic
  • Fukuoka, Japan
    • Kokorono Clinic Hirao
  • Fukuoka, Japan
    • Mental Clinic Sakurazaka
  • Fukuoka, Japan
    • Shinseikai Kaku Mental Clinic
  • Fukuoka, Japan
    • Uematsu Mental Clinic
  • Gunma, Japan
    • Ichikawa Clinic
  • Hokkaido, Japan
    • Higashi-Sapporo Mental Clinic
  • Hokkaido, Japan
    • Kawamura Mental Clinic
  • Hokkaido, Japan
    • Minami1jo Mental Clinic
  • Hokkaido, Japan
    • Sapporo Kobushi Clinic
  • Hokkaido, Japan
    • Shimode Mental Clinic
  • Hyōgo, Japan
    • Tatsuta Clinic
  • Kanagawa, Japan
    • Yutaka Clinic
  • Miyazaki, Japan
    • Ai Clinic
  • Osaka, Japan
    • Inoue Clinic
  • Tokushima, Japan
    • Yamaguchi Mental Clinic
  • Tokyo, Japan
    • Maynds Tower Mental Clinic
  • Tokyo, Japan
    • Harai Clinic
  • Tokyo, Japan
    • Iidabashi Mental Clinic
  • Tokyo, Japan
    • Ikebukuro Olive Mental Clinic
  • Tokyo, Japan
    • Meguroeki Higashiguchi Mental Clinic
  • Tokyo, Japan
    • Monzen-nakacho Mental Clinic
  • Tokyo, Japan
    • Sangenjaya Nakamura Mental Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Japanese participants (sex not specified)
2. Participants who, in the opinion of the principal (or sub-investigator), are capable of understanding the content of the clinical trial and complying with its requirements
3. Participants diagnosed with social anxiety disorder based on DSM-5-TR (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision) criteria, as determined through an interview using the M.I.N.I. (Mini-international neuropsychiatric interview)
4. Outpatients
5. Participants with a LSAS-J (Liebowitz Social Anxiety Scale Japanese version) total score of 70 or higher and a CGI-S (Clinical global impression-Severity) score of 4 or higher

Exclusion Criteria:

1. Participants with a current or past history of psychiatric or neurological disorders that meet any of the following criteria:

   • Participants with a comorbid psychiatric disorder other than social anxiety disorder as defined by DSM-5-TR (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision) (assessed using the M.I.N.I. (Mini-international neuropsychiatric interview))
   • Participants with a comorbid or past history of schizophrenia or other psychotic disorders as defined by DSM-5-TR (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision)
   • Participants with neurodevelopmental disorders, neurocognitive disorders, or personality disorders (excluding avoidant personality disorder) as defined by DSM-5-TR
2. Participants who have been primarily diagnosed with a disorder other than social anxiety disorder according to DSM-5-TR (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision) criteria within 24 weeks prior to screening
3. Participants with a MADRS (Montgomery Åsberg Depression Rating Scale) total score of 15 or higher
4. Participants who, in the opinion of the principal (or sub-investigator), have not responded to at least two different SSRIs (Selective serotonin reuptake inhibitor), each administered at an adequate dose for at least 10 weeks, in treating social anxiety disorder

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ONO-1110	Drug: Placebo; Placebo tablets once daily; Drug: ONO-1110; ONO-1110 tablets once a day
Placebo Comparator: Placeo	Drug: Placebo; Placebo tablets once daily; Drug: ONO-1110; ONO-1110 tablets once a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in L-SAS J(Liebowitz Social Anxiety Scale Japanese version) total score from baseline to Week 12 of the treatment period	Up to 19 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The transition of LSAS-J(Liebowitz Social Anxiety Scale Japanese version) total score from baseline to Week 8 of the treatment period		Up to 19 weeks
The transition of LSAS-J(Liebowitz Social Anxiety Scale Japanese version) Fear or Anxiety score from baseline to Week 8 of the treatment period		Up to 19 weeks
The transition of LSAS-J(Liebowitz Social Anxiety Scale Japanese version) Avoidance score from baseline to Week 8 of the treatment period		Up to 19 weeks
Responder rates of LSAS-J(Liebowitz Social Anxiety Scale Japanese version) total score at 1, 2, 4, 6, 8,10and 2 weeks of the treatment period	Responder is defined as a reduction of 30% or more in LSAS-J(Liebowitz Social Anxiety Scale Japanese version)total score from baseline	Up to 19 weeks
Remitted patient rates of LSAS-J(Liebowitz Social Anxiety Scale Japanese version) total score at 1, 2, 4, 6, 8, 10 and 12 weeks of the treatment period	Remitted patient is defined as a LSAS-J(Liebowitz Social Anxiety Scale Japanese version) total score of 30 or less.	Up to 19 weeks
Transition of CGI-S(Clinical Global Impression of illness Severity) score from baseline to Week 12 of the treatment period		Up to 19 weeks
Transition of SDISS(Sheehan Disability Scale) score from baseline to Week 12 of the treatment period		Up to 19 weeks
Plasma ONO-1110 concentrations		Up to 19 weeks
Adverse Events		Up to 19 weeks

Collaborators and Investigators

• Sponsor: Ono Pharmaceutical Co. Ltd
• Investigators: Study Director: Project Leader, Ono Pharmaceutical Co. Ltd

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026

Study Registration Dates

• First Submitted: January 28, 2025
• First Submitted That Met QC Criteria: January 28, 2025
• First Posted (Actual): February 3, 2025

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 18, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Phobic Disorders; Anxiety Disorders; Phobia, Social
• Other Study ID Numbers: ONO-1110-08; jRCT2031240578 (Registry Identifier: Japan Registry of Clinical Trials)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No